Toshedra 7 mg/ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Toshedra 7 mg/ml Syrup

Dry extract of Hedera helix L. (ivy)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for use of this medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

Contents of the leaflet

1. What Toshedra is and what it is used for
2. What you need to know before taking Toshedra
3. How to take Toshedra
4. Possible adverse effects
5. How to store Toshedra
6. Contents of the pack and other information

1. What Toshedra is and what it is used for

Toshedra is an expectorant.

Toshedra is a herbal medicine used as an expectorant for productive cough associated with benign bronchial conditions. It helps facilitate the elimination of mucus.

Toshedra is indicated for use in adults, adolescents, and children over 2 years of age.

2. What you need to know before starting to take Toshedra

Do not take Toshedra:

• If you are allergic to ivy (Hedera helix L.), to plants of the Araliaceae family, or to any of the other components of this medicine (listed in section 6).

• Do not administer to children under 2 years of age, as there is a risk that respiratory symptoms may worsen.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Toshedra.

Medical or pharmaceutical advice should be sought in cases of dyspnea (difficulty breathing), fever, or purulent sputum.

Concomitant use with other antitussives such as codeine or dextromethorphan is not recommended without prior medical consultation.

Caution is recommended in patients with gastritis or gastric ulcer.

If symptoms worsen or no improvement is observed after 7 days of starting treatment, the treatment should be discontinued and medical advice should be sought.

Children

In children aged 2 to 4 years with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

Taking Toshedra with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

There are no adequate and well-controlled studies in pregnant women; therefore, administration is not recommended.

Lactation:

There is no information on the passage of the components of this medication into breast milk; therefore, administration to women during lactation is not recommended.

Fertility

There are no available data regarding fertility.

Driving and Use of Machines

Studies on the effects on the ability to drive and use machines have not been conducted.

Toshedra contains sorbitol.

This medicine contains 385 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor before taking this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

3. How to take Toshedra

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years of age: 5 ml of syrup, 3 times a day (equivalent to 105 mg daily of dried ivy leaf extract).

Children between 6 and 12 years of age: 5 ml of syrup, 2 times a day (equivalent to 70 mg daily of dried ivy leaf extract).

Children from 2 to 5 years of age: 2.5 ml of syrup, 2 times a day (equivalent to 35 mg daily of dried ivy leaf extract).

In children aged 2 to 4 years with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

Children under 2 years of age: Toshedra must not be given to children under 2 years of age due to the risk of worsening respiratory symptoms.

If you think that the effect of Toshedra is too strong or too weak, please inform your doctor or pharmacist.

Toshedra is taken orally. Shake the bottle well before use.

To ensure you always take the recommended dose, use the dosing cup provided, which is graduated up to 10 ml.

Consult a doctor if symptoms worsen or do not improve after one week of treatment.

If you take more Toshedra than you should

If you have taken more Toshedra than you should, or in case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and the amount ingested.

Do not exceed the recommended daily dose. Ingestion of significantly higher amounts (more than three times the daily dose) may cause nausea, vomiting, and diarrhea.

In this case, you should consult your doctor.

If you forget to take Toshedra

Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequent (may affect between 1 and 10 out of 100 patients): gastrointestinal system reactions such as nausea, vomiting, or diarrhea have been reported.

Uncommon (may affect between 1 and 10 out of 1,000 patients): allergic reactions such as urticaria, skin rashes, difficulty breathing (dyspnea) have been reported.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

If you notice symptoms of allergy (hypersensitivity), stop taking Toshedra.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Toshedra

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging, following “EXP”. The expiry date refers to the last day of the month indicated.

After opening the container, the product expires after 12 months. Remember to record the date of opening on the medicine’s packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Sigre Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Toshedra 7 mg/ml syrup:

The active substance is: dried leaf extract of Hedera helix. 2.5 ml of Toshedra contain 17.5 mg of dried leaf extract of Hedera helix L. (ivy) (4-8:1), extraction solvent ethanol 30% (m/m). The other components are: liquid non-crystallizable sorbitol (E-420), xanthan gum, potassium sorbate, citric acid, purified water, simethicone, and cherry flavor.

Appearance of the product and contents of the container:

The medicine is supplied in amber-colored PET bottles of 100 ml, 150 ml, or 200 ml, with a polypropylene child-resistant safety closure. It includes a colorless graduated polypropylene dosing cup marked in 2.5, 5, and 10 ml increments.

Marketing Authorization Holder and Manufacturing Responsible Party:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the most recent review of this leaflet: November 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/